I-PORT

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

PATTON MEDICAL DEVICES

The following data is part of a premarket notification filed by Patton Medical Devices with the FDA for I-port.

Pre-market Notification Details

• Device ID: K052389
• 510k Number: K052389
• Device Name: I-PORT
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: PATTON MEDICAL DEVICES PO BOX 1490 Eagle, ID 83616
• Contact: Fred Schlador
• Correspondent: Laura Danielson; TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-08-31
• Decision Date: 2005-09-09
• Summary: summary